A clinical trial commonly refers to a rigorously controlled test of a new drug or a new invasive medical device on human subjects or patients. Prior to being made available to general population for use, in the United States, drugs and invasive medical devices must pass this rigorous testing set forth commonly known as a clinical trial. Compliance of clinical trials is regulated by the Food and Drug Administration (FDA) which is a federal agency responsible for overseeing trade in and the safety of food and drugs in the United States.
Today, the most commonly performed clinical trials are used to evaluate drugs or medical therapies in strictly scientifically controlled settings. Probably the most important purpose of such trials is to determine whether the drugs or treatment options are safe, effective, and better than the current standard of care presently available. Because the potential effects of incorrectly assessing a drug or medical therapy can be catastrophic, extreme care must be given in monitoring patient's health and progress.
Conventionally, most clinical trials, especially drug trials, are designed to be randomized and oftentimes include placebo substitutes for the actual drug on trial. Essentially, each subject is randomly assigned to receive a medication or treatment, which might in fact be the placebo rather than the actual drug on trial. In may cases, neither the subjects nor individuals monitoring the study know which treatment is being administered to any given subject; and, in particular, none of those involved in the study know which subjects are being administered a placebo.
Throughout the trial, subjects are monitored both within a controlled setting as well as throughout daily life. As such, oftentimes, a written journal or record is kept that memorializes events such as, when the drug was taken, what dosage was taken, what effects, if any, were felt after taking the medication, etc. This manually gathered data is analyzed and recorded in order to determine compliance within the scope of the FDA regulated clinical trial. However, the self-reporting mechanisms (e.g., written journals and records) are notorious causes of inaccurate data. Moreover, manual supervision and reporting is burdensome and extremely costly to the patient as well as to the clinical trial as a whole.
Today, many clinical trials require large numbers of participants in order to obtain useful results as well as to adhere to FDA guidelines. Oftentimes, trials take place in multiple geographical areas or even countries. As the subjects of the trials become more and more dispersed, monitoring and regulating dosage, effects, etc. is becoming increasingly difficult and expensive. Moreover, the size of the class of participants as well as the distributed nature of the participants can also lead to an increase the margin of error and thus, an increase in risk of to the public in the event of an incorrectly justified FDA approval.